The Well@Home Monitor by Patient Care technologies Model 179-2150 Intended to be used as a clinical tool for remotely monitoring a patient's health status at home or in another healthcare facility on a spot check basis.
This recall has been terminated (originally issued August 3, 2010).
- Company
- Zoe Medical Incorporated
- Recall Initiated
- February 2, 2009
- Posted
- August 3, 2010
- Terminated
- August 3, 2010
- Recall Number
- Z-2166-2010
- Quantity
- 62
- Firm Location
- Topsfield, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Touch panel may become unresponsive.
Distribution
Nationwide Distribution -- MA and MD.
Lot / Code Info
Serial numbers WFD5373, WFD5374, WFD5375, WFD5376, WFD5377, WFD5378, WFD5379,WFD5380, WFD5381, WFD5382, WFD5383, WFD5384, WFD5385, WFD5386, WFD5387, WFD5388, WFD5389, WFD5390, WFD5392, WFD5393, WFD5394,WFD5395, WFD5396, WFD5398, WFD5399, WFD5400, WFD5401, WFD5402, WFD5403, WFD5404, WFD5405, WFD5406, WFD5407, WFD5408, WFD5409,WFD5410, WFD5411, WFD5412, WFD5413, WFD5414, WFD5415, WFD5416, WFD5417, WFD5418, WFD5419, WFD5420, WFD5421, WFD5422, WFD5423,\/VFD5424, VVFD5425, WFD5426, WFD5427, WFD5428, WFD5429, WFD5431, WFD5432, WFD5435, WFD5436, WFD5437, WFD5438, and WFD5439.
Root Cause
Component change control
Action Taken
Zoe Medical notified the 2 distributors by e-mail on January 26, 2009 and Feb 6, 2009 of the recall, requesting return of the units for correction.